A Congressional Hearing: “The Fungal Meningitis Outbreak: Could It Have Been Prevented?” Is Scheduled for Wednesday, November 14, 2012

The Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations issued a Majority Memorandum announcing that it is holding a hearing titled “The Fungal Meningitis Outbreak: Could It Have Been Prevented?” The hearing will begin at 10:00 am at Room 2123 of the Rayburn House Office Building. The hearing will consider the facts surrounding the recent meningitis outbreak and other infections linked to reportedly contaminated injectable products that were made and distributed by New England Compounding Center (“NECC”). The hearing will also examine the history of state and federal complaints and actions taken against NECC and its affiliated entities by both the FDA and the Massachusetts Department of Public Health. Listed invitation-only witnesses include: Ms. Joyce Lovelace (whose husband, it has been reported, died of a stroke after receiving steroid injections); Barry Cadden (President, Co-owner and Director of Pharmacy, NECC); Margaret Hamburg (FDA Commissioner); and Lauren Smith (Interim Commissioner, Massachusetts Department of Public Health). House Energy and Commerce Committee Chairman Fred Upton (R-MI), after consultation with Ranking Member Henry A. Waxman (D-CA), issued a subpoena for Barry Cadden to appear because, through his counsel, Mr. Cadden declined to appear voluntarily. The 25-page Memorandum describes the background of the current meningitis outbreak and the state and federal investigation thereof. It also discusses the federal and state investigative history of NECC since Massachusetts approved the company’s pharmacy license application in 1998.

The following issues will be explored at Wednesday’s hearing:

Whether FDA’s and the Massachusetts Board of Pharmacy’s enforcement actions were appropriate in light of deficiencies and violations reported by State and Federal inspectors at NECC since as early as 2002.

Whether FDA should have pursued any enforcement actions against the NECC, when FDA emphasized in 2003 the potential for serious public health consequences if the company’s compounding practices, in particular those relating to sterile products, were not improved.

Prior to this outbreak, according to the Memorandum, the Massachusetts Board of Pharmacy had investigated at least twelve separate complaints relating to NECC and its management. While many of these complaints covered NECC’s sales and marketing tactics, several were associated with serious adverse events and uncovered deficiencies with NECC’s compounding operations, according to the report. The Committee will examine whether NECC should have been permitted to maintain its pharmacy license despite repeated violations.

What did state and federal authorities do to confirm that sufficient corrective measures were taken after these inspections? How did they communicate with each other to ensure such responses were adequate to protect the public health?